Comparative Study of EDP-420 Versus Another Antibiotic in the Treatment of Community Acquired Pneumonia

• Sponsor: Enanta Pharmaceuticals (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT00270517
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 13.2

Study Details

Study Description

Brief Summary

This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia

Condition or Disease	Intervention/Treatment	Phase
Community Acquired Pneumonia	Drug: EDP-420 / Duration of Treatment - 3 days; Drug: Telithromycin / Duration of Treatment - 7 days	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
• Study Start Date: Dec 1, 2005
• Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Clinical Cure 7-14 days after end of therapy []

Secondary Outcome Measures

1. Bacteriological response []

2. Radiographic response []

3. Change in signs and symptoms []

4. Safety []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia.

• Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact

• If female, must be non-lactating and at no risk for pregnancy

Exclusion Criteria:

• Other infections

• Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy

• History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins

• Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality

• Requirement of parenteral antimicrobial therapy for treatment of pneumonia

• Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism

• Immunocompromised subjects

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Enanta Pharmaceuticals, Inc.	Watertown	Massachusetts	United States	02472

Sponsors and Collaborators

• Enanta Pharmaceuticals

Investigators

• Study Director: Study Director, Enanta Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00270517
• Other Study ID Numbers: EDP420-05-006
• First Posted: Dec 28, 2005
• Last Update Posted: Sep 19, 2006
• Last Verified: Sep 1, 2006

• Additional relevant MeSH terms: Pneumonia; Telithromycin

Study Results

No Results Posted as of Sep 19, 2006